Loyd V. Allen, Jr., PhD
Professor Emeritus
College of Pharmacy,
University of Oklahoma
Oklahoma City

Method of Preparation: Calculate the quantity of each ingredient for the amount to be prepared. Accurately weigh or measure each ingredient. Before compounding, tap the top and bottom of the lidocaine hydrochloride (HCl) bottle. Open the suspension bottle and empty the lidocaine HCl powder into the suspension. Likewise, tap the top and bottom of the diphenhydramine HCl bottle. Remove the cap. Because of the hygroscopic nature and small volume of the powder, use the enclosed spatula to empty the contents into the mouthwash suspension. Close the suspension bottle and vigorously shake it vertically for approximately 20 to 30 seconds. The appropriate quantities of diphenhydramine HCl powder and lidocaine HCl powder have been packaged in each bottle to deliver the required dose of each drug. Residual quantities remaining in the bottles after emptying need not be rinsed out. Package and label.

Use: This preparation is used to ease mucositis symptoms caused by some forms of chemotherapy and radiation therapy, as well as for aphthous ulcers, other oral ulcers, and other mouth pain.

Packaging: Package in the container in which it is provided and compounded.

Labeling: Keep out of reach of children. Avoid contact with the eyes. Keep container tightly closed. Keep refrigerated. Protect from light. Protect from freezing. Shake well before each use. Discard after ____ [time period].

Stability: Based on real-time controlled room temperature and humidity testing, the finished, compounded Mouthwash BLM Compounding product is stable for at least 180 days.

Quality Control: Quality-control assessment can include weight/volume, pH, specific gravity, active drug assay, color, rheologic properties, physical observation, and physical stability (discoloration, foreign materials, gas formation, mold growth).

Discussion: This formula is equivalent to the active ingredients in compounded Magic Mouthwash [Benadryl Elixir:Lidocaine HCl 2% Viscous:Maalox Suspension (1:1:1 v/v/v)]. The Mouthwash BLM Compounding Kit contains premeasured diphenhydramine HCl powder, lidocaine HCl powder, and mouthwash suspension (aluminum hydroxide, magnesium hydroxide, and simethicone, plus inactive ingredients). The 119-mL size of the compounded preparation contains diphenhydramine HCl 0.1 g, lidocaine HCl 0.8 g, and FIRST Mouthwash Suspension 118 mL.

Diphenhydramine HCl (C₁₇H₂₁NO.HCl, MW 291.82), an H1-receptor antagonist used for the relief of hypersensitivity reactions, occurs as a white, odorless, crystalline powder. It slowly darkens on exposure to light, and its solutions are practically neutral. Diphenhydramine HCl is freely soluble in water and in alcohol. It elicits mild anesthetic properties when used topically. Read more.

FOR IMMEDIATE RELEASE

Woburn, MA (June 12, 2019)—CutisPharma, Inc. announced today its acquisition of Silvergate Pharmaceuticals, Inc. and the unveiling of its new corporate brand for the unified company: Azurity Pharmaceuticals.
“I am thrilled to announce the combination of two strong companies with a rich legacy meeting the needs of underserved patients, such as children and the elderly,” said Neal I. Muni, MD, MSPH, Azurity Pharmaceuticals’ Chief Executive Officer. “Azurity’s mission, to make safe, high-quality treatments for patients requiring customized formulations for their care, is significantly bolstered by our combined resources and capabilities.” Read more.